Positioning fluoroscopy procedures
Gastro-intestinal examinations
Urogenital tract examinations
Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.
In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
The DR 800 is not intended for mammography applications.

Device Description

Agfa's DR 800 with Tomosynthesis a tomographic and fluoroscopic x-ray system (product codes IZF and JAA) intended to capture tomographic slices of the human body. The DR 800 is a floormounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital and wide dynamic range capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

AI/ML Overview

The Agfa DR 800 with Tomosynthesis underwent bench testing and software verification and validation to demonstrate substantial equivalence to its predicate devices, the GE Medical System's Discover XR656 with VolumeRAD (K132261) and Agfa's previous version of the DR 800 with MUSICA Dynamic (K180589). The primary focus of the testing for this submission was on the new Digital TomoSynthesis (DTS) software and its performance in generating tomographic slices.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and the Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Technical & Acceptance Testing	All deviations or variances are documented, addressed in CR&T (Corrective and Remedial Actions) documentation, and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed.	Verification and validation testing confirmed the device meets performance, safety, usability, and security requirements. Pediatric indications were also taken into account. Results were verified and validated. Technical and acceptance testing was completed on the DR 800 with Tomosynthesis to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CR&T documentation and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed.
Usability & Functionality Evaluation	The results of these tests fell within the acceptance criteria for the DR 800 X-ray system.	Usability and functionality evaluations were conducted with qualified independent radiographers and internal experts. The results of these tests fell within the acceptance criteria for the DR 800 X-ray system; therefore, the DR 800 supports a radiographic, fluoroscopic, and tomosynthesis workflow including dynamic and static imaging, continuous and rapid sequence exams, tomographic slices calibration, and positioning.
Image Quality Validation (Adults)	The reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria. DTS images were suitable for diagnosis.	Image Quality Validation testing was conducted using anthropomorphic phantoms and evaluated by qualified independent radiographers and internal experts. The image quality validation included testing a full range of applications for the DR 800 X-ray system with Tomosynthesis compared to reference images from the primary predicate GE Discovery XR656 with VolumeRAD (K132261) using anonymized adult phantoms. The test results indicated that the reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria and that the DR 800 with Tomosynthesis is capable of making DTS studies for adult patients. The test results showed MUSICA Digital TomoSynthesis (DTS) images were suitable for diagnosis for adult patients.
Image Quality Validation (Pediatric)	The reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria. Both 5x the dose and 10x the dose images were clinically sufficient and within the intended use, and DTS images were suitable for diagnosis for pediatric patients.	Image Quality Validation testing was conducted using anthropomorphic phantoms and evaluated by qualified independent radiographers and internal experts. The image quality validation included testing using anonymized pediatric phantoms. The pediatric phantom image quality validation testing analyzed five tomographic slices at 5x the dose and five tomographic slices at 10x the dose. Both the 5x the dose and 10x the dose images are clinically sufficient and within the intended use. The test results indicated that the reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria and that the DR 800 with Tomosynthesis is capable of making DTS studies for pediatric patients. The test results showed MUSICA Digital TomoSynthesis (DTS) images were suitable for diagnosis for pediatric patients.
Software Risk Assessment	No risks identified in the Not Acceptable Region. The device is assumed to be safe, and the benefits of the device outweigh the residual risk.	During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field. For the NX4.x.21 (NX Mentor) there are a total of 322 risks in the broadly acceptable region and 27 risks in the ALARP (As Low As Reasonably Practicable) region with only eight of these risks identified. Zero risks were identified in the Not Acceptable Region.
Electrical Safety & EMC Testing	Compliance with various IEC 60601 standards and FDA Subchapter J.	The DR 800 with Tomosynthesis is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 - 1020.32. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, and IEC 60601-2-54 was confirmed.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a numerical count of cases/images. The testing involved "anthropomorphic phantoms" for image quality evaluation, including both adult and pediatric phantoms. The pediatric phantom testing analyzed "five tomographic slices at 5x the dose and five tomographic slices at 10x the dose."
Data Provenance: The data provenance is from bench testing using anonymized anthropomorphic phantoms. This indicates that the data is prospective in the sense that the phantoms were specifically used for this testing, but it is not from human patients. The country of origin of the data is not specified, but the manufacturer is Agfa N.V. (Belgium).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: "Qualified independent radiographers and internal experts" were used for usability, functionality, and image quality evaluations. The exact number of each group is not specified.
Qualifications of Experts: They are described as "qualified independent radiographers and internal experts" and "qualified radiologists" (in the "Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence" section). Specific details like years of experience or subspecialty are not provided.

4. Adjudication Method for the Test Set

The document implies that the "qualified independent radiographers and internal experts" evaluated the images and that the results "fell within the acceptance criteria" or "passed the acceptance criteria," suggesting a consensus or individual assessment against predefined criteria. However, a specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. The study design described is a bench test comparison of the device against a predicate device's reference images using phantoms, with evaluation by human experts, rather than an assessment of human reader performance with or without AI assistance. The device itself is an imaging system, not an AI-powered diagnostic tool for interpretation assistance in the sense of comparing human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone evaluation of the algorithm's output was done, as part of the image quality validation. The "reconstruction software of the image processing for Digital TomoSynthesis (DTS)" was evaluated to ensure the generated tomographic images were suitable for diagnosis. This is an assessment of the algorithm's output (the tomographic slices) without direct human intervention in the image generation process, beyond setting up the acquisition parameters.

7. The Type of Ground Truth Used

The ground truth for the image quality evaluation was based on comparison to reference images from the primary predicate device (GE Discovery XR656 with VolumeRAD - K132261) using anthropomorphic phantoms, and expert assessment by "qualified independent radiographers and internal experts" confirming the images were "suitable for diagnosis" and "clinically sufficient." It is not pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set for the MUSICA DTS software. It mentions that "The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with MUSICA Dynamic (K180589) and other devices in Agfa's radiography portfolio today... The addition of the tomographic image processing is similar to the predicate device (K132261)." This suggests leveraging existing, previously trained algorithms or development methodologies, rather than describing a specific new training dataset for this submission.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. As noted above, the submission emphasizes similarity to existing, cleared technologies, rather than detailing the unique training of a novel algorithm from scratch.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 1, 2019

Agfa N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager, North America Agfa US Corp. 10 South Academy Street GREENVILLE SC 29601

Re: K183275

Trade/Device Name: DR 800 with Tomosynthesis Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF, JAA Dated: November 20, 2018 Received: November 23, 2018

Dear Ms. Cavanagh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Nils

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K183275

Device Name

DR 800 with Tomosynthesis

Indications for Use (Describe)

The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

· Positioning fluoroscopy procedures
· Gastro-intestinal examinations
· Urogenital tract examinations
· Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.

In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesize tomographic slices from a single tomographic sweep.

The DR 800 is not intended for mammography applications.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5. 510(K) Summary

{4}------------------------------------------------

{5}------------------------------------------------

510(K) SUMMARY

Agfa N.V. DR 800 with Tomosynthesis

I. SUBMITTER

Agfa N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Wim Govaerts, Prepared: November 20, 2018 Telephone: + 32 3444 6246

DEVICE II.

Name of Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF

Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic X-ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA

PREDICATE DEVICES III.

This is a 510(k) for Agfa's DR 800, which is tomographic and fluoroscopic x-ray system. It is substantially equivalent to GE Medical System's Discover XR656 with VolumeRAD (K132261) and Agfa's previous version of the DR 800 with MUSICA Dynamic (K180589).

Primary Predicate:

Name of Device: Discover XR656 with VolumeRAD Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF

Reference Predicate:

Name of Device: DR 800 with MUSICA Dynamic Common Name: System, X-Ray, Fluoroscopic, Image-Intensified Classification Name: Fluoroscopic X-ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA

{6}------------------------------------------------

The DR 800 with MUSICA Dynamic (K180589) predicate has not been subject to a design-related recall.

The Discovery XR656 with VolumeRAD (K132261) primary predicate device was part of a Class II recall initiated on 8/20/2014 and terminated by CDRH on 2/20/2015. The recall was for nylon hooks used to support the FlashPad detector on the wall stand. No injuries were reported.

IV. DEVICE DESCRIPTION

This submission is to add the newest version of the DR 800 with Tomosynthesis to Agfa's radiography portfolio.

The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with MUSICA Dynamic (K180589) and other devices in Agfa's radiography portfolio today which includes DR 600 (K152639) and DR 400 (K141192). The addition of the tomographic image processing is similar to the predicate device (K132261).

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's DR 800 with MUSICA Dynamic (K180589) with the exception that it has additional MUSICA Digital TomoSynthesis (DTS) software for processing tomographic slices. The Discovery XR656 with VolumeRAD (K132261) contains similar software for processing tomographic slices of human anatomy. It uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect. Laboratory data and image quality evaluations conducted with independent radiologists confirm that performance is equivalent to the predicates.

Configuration information for the flat-panel detectors can be found in the DR 14s (K161368) and DR 800 (K180589) User Manuals. The DR 14s and RF FL4343 detectors can be integrated in an X-ray system that communicates to a workstation. The Service Manual details the possible configurations and integrations with the NX workstation and X-ray generator. All of Agfa's DR X-ray systems (i.e. DX-D 100-K103597, DX-D 300-K103050, DX-D 600-K112670, DR 400-K141192, DR 600-K152639, DR 800 with MUSICA Dynamic -K180589) will integrate with the detectors. The NX4.x.21 Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components.

V. INDICATIONS FOR USE

The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

Positioning fluoroscopy procedures
Gastro-intestinal examinations

{7}------------------------------------------------

Urogenital tract examinations
. Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.

In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-Ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

The DR 800 is not intended for mammography applications.

NOTE: The mammography applications embedded in the MUSICA software are for previously cleared CR imaging applications (K081963) and not intended for direct radiography (DR), fluoroscopic or tomosynthesis imaging. Furthermore, the additional mammography software is only available through additional license keys that must be purchased. These license keys are only available outside of the USA.

PEDIATRIC USE SUMMARY

The DR 800 is intended for general populations, including adult and pediatric patients of all ages. Specific design features of the DR 800 for pediatric use include but not limited to using the specific AEC values, NX protocol settings per pediatric age range and automatic brightness control with pediatric settings to lower the dose for pediatric fluoroscopic applications.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICES

Agfa's DR 800 with Tomosynthesis and GE Medical System's Discovery XR656 with VolumeRAD primary predicate device (K132261) are tomographic x-ray imaging devices, Product Code IZF. The DR 800 with Tomosynthesis also has product code JAA which is identical the Agfa DR 800 with MUSICA Dymanic predicate device (K180589). Agfa's DR 800 is substantially equivalent to the primary predicate device (K132261) in that it uses precisely the same technology to capture and transmit images. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital and wide dynamic range image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's DR 800 with MUSICA Dynamic (K180589) with the exception that it has additional MUSICA DTS software for processing tomographic slices. The Discovery XR656 with VolumeRAD (K132261) contains similar software for processing tomographic slices of human anatomy. It uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.

{8}------------------------------------------------

The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with MUSICA Dynamic (K180589) and other devices in Agfa's radiography portfolio today which includes DR 600 (K152639) and DR 400 (K141192). The addition of the tomographic image processing is similar to the predicate device (K132261).

Agfa's DR 800 with Tomosynthesis has an Indications For Use statement virtually identical to the predicate device (K180589) except it includes the addition of tomosynthesis. Intended uses are the same. The devices have the same technological characteristics.

The DR 800 indications for use is equivalent to the primary predicate (K132261) because both include the delineation of anatomical areas and imaging applications and application of tomosynthesis. The DR 800 and both predicate devices (K180589 & K132261) include the statement that the device is not indicated for mammography.

Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect.

Table 1 on the next page summarizes the similarities and differences between the new device and predicate.

{9}------------------------------------------------

Agfa N.V. Premarket Notification: DR 800 with Tomosynthesis

	DR 800 Tomosynthesis(NEW DEVICE)Agfa	Discovery XR656 Volume RAD(PRIMARY PREDICATE -K132261)GE Medical Systems	DR 800 MUSICA Dynamic(REFERENCEPREDICATE-K180589)Agfa
Communications	Same as both predicates	DICOM	DICOM
Flat PanelDetectors	Same as both predicates	Flat Panel Detectors	Flat Panel Detectors
DetectorMaterial	Same as both predicates	Gadolinium Oxysulfide (GOS) orCesium Iodide (CsI) scintillator	Gadolinium Oxysulfide(GOS) or Cesium Iodide(CsI) scintillator
Detector Sizes	Same as predicate K180589	40.4 cm x 40.4 cm	17x17 in.14 x 17 in10 x 10 in
Field Sizes	Same as predicate K180589	41 x 41 cm35 x 41 cm24 x 30 cm18 x 24 cm	43 x 43 cm30 x 30 cm20 x 20 cm15 x 15 cm
Pixel Size	Same as predicate K180589	200 um	148 um
Dynamic Range	Same as predicate K180589	14 bit	16 bit
Matrix Size	Same as predicate K180589	2022 x 2022	Static - 2880 x 2880Dynamic - 1024 x 1024
Power Supply	Same as both predicates	50-60 Hz100-240V auto ranging	50-60 Hz100-240V auto ranging
OperatorWorkstation	Same as predicate K180589	Diagnostic Workstation	Agfa NX
Imageprocessing	MUSICA Dynamic,MUSICA2MUSICA3/3+MUSICA DTS	VolumeRAD, Dual Energy,Tissue Equalization, Auto ImagePaste	MUSICA Dynamic,MUSICA2MUSICA3/3+
TabletopFeatures	Same as predicate K180589	Tilt +/- 90°225 x 89 cm220kg - 320 kg maximum weight	Tilt +/- 90°240 x 80 cm265 kg maximum weight
Generators	Same as both predicates	Choice of three models:50, 65KW. 80 KW	Choice of three models:50, 65KW, 80 KW
Operating System	Same as both predicates	Windows 7, 8, 8.1, 10	Windows 7, 8, 8.1, 10
Display System	Same as predicate K180589	Separately cleared medicaldisplay	Separately cleared medicaldisplay (K051901)

{10}------------------------------------------------

Agfa N.V. Premarket Notification: DR 800 with Tomosynthesis

Indications forUse Statements	The DR 800 system isindicated for performingdynamic imagingexaminations (fluoroscopyand/or rapid sequence) of thefollowinganatomies/procedures:Positioning fluoroscopyprocedures, Gastro-intestinalexaminations, Urogenital tractexaminations, andAngiography. It is intendedto replace fluoroscopicimages obtained throughintensifier technology. Inaddition, the system isintended for projectradiography of all body parts.In addition, the systemprovides the AgfaTomosynthesis option, whichis intended to acquiretomographic slices of humananatomy and to be used withAgfa DR X-ray systems.Tomosynthesis is used tosynthesize tomographic slicesfrom a single tomographicsweep. The DR 800 is notintended for mammographyapplications.	The Discovery XR656 isintended to generate digitalradiographic images of the skull,spinal column, chest, abdomen,extremities, and other body partsin patients of all ages.Applications can be performedwith the patient sitting, standing,or lying in the prone or supineposition and is intended for use inall routine radiography exams.When the VolumeRAD option isincluded on the system, thesystem can generate tomographicimages of human anatomyincluding the skull, spinalcolumn, chest, abdomen,extremities, and other body partsin patients of all ages.VolumeRAD can also be used todetect lung nodules for patientsundergoing thoracic imaging.VolumeRAD generatesdiagnostic images of the chestthat aid the radiologist inachieving superior detectabilityof lung nodule versus posterior-anterior and left lateral views ofthe chest, at a comparableradiation level. This device is notintended for mammographicapplications.	The DR 800 system isindicated for performingdynamic imagingexaminations (fluoroscopyand/or rapid sequence) ofthe followinganatomies/procedures:Positioning fluoroscopyprocedures, Gastro-intestinalexaminations, Urogenitaltract examinations, andAngiography. It is intendedto replace fluoroscopicimages obtained throughintensifier technology. Inaddition, the system isintended for projectradiography of all bodyparts. The DR 800 is notintended for mammographyapplications.
-----------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 1: Device Comparison Table

VII. PERFORMANCE DATA

Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols were evaluated by qualified individuals employed by the sponsor and independent radiologists to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.

Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. Pediatric indications were also taken into account. Results were verified and validated.

No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.

Bench Testing

Clinical image quality evaluations for adults and pediatric patients, performance/functionality and usability data has been provided.

{11}------------------------------------------------

Technical and acceptance testing was completed on the DR 800 with Tomosynthesis in ● order to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CR&T documentation and verified. All mitigations have been tested and passed. All design input requirements have been tests and passed. All planned verification activities have been successfully completed.
. Usability and functionality evaluations were conducted with qualified independent radiographers and internal experts. The results of these tests fell within the acceptance criteria for the DR 800 X-ray system therefore, the DR 800 supports a radiographic, fluoroscopic, and tomosynthesis workflow including dynamic and static imaging, continuous and rapid sequence exams, tomographic slices calibration, and positioning.
Image Quality Validation testing was conducted using anthropomorphic phantoms and ● evaluated by qualified independent radiographers and internal experts. The image quality validation included testing a full range of applications for the DR 800 X-ray system with Tomosynthesis compared to reference images from primary predicate GE Discovery XR656 with VolumeRAD (K132261) using anonymized adult and pediatric phantoms. The pediatric phantom image quality validation testing analyzed five tomographic slices at 5x the dose and five tomographic slices at 10x the dose. Both the 5x the dose and 10x the dose images are clinically sufficient and within the intended use. The test results indicated that the reconstruction software of the image processing for Digital TomoSynthesis (DTS) of the DR 800 X-ray system passed the acceptance criteria and that the DR 800 with Tomosynthesis is capable of making DTS studies for both adult and pediatric patients. The test results showed MUSICA Digital TomoSynthesis (DTS) images were suitable for diagnosis for both adult and pediatric patients.

Performance data including clinical image quality evaluations for adults and pediatric patients, performance/functionality and usability data are adequate to ensure equivalence.

Software Verification and Validation Testing

Verification and validation plans comprise of test protocols. The complete device has been certified and validated. During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field.

For the NX4.x.21 (NX Mentor) there are a total of 322 risks in the broadly acceptable region and 27 risks in the ALARP region with only eight of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk. The software risk assessment is assessed on solution level for the DR 800 and also includes separate risk assessments for the NX4.x.21 software and XRDI.

The term "Level of Concern" means the level of risk that the software device is determined to be if the software were to fail. The Level of Concern for the DR 800 and NX4.x.21 has been determined to be moderate.

{12}------------------------------------------------

Electrical Safety and Electromagnetic Compatibility (EMC) Testing:

IEC 60601-1: 2012 Medical Electrical Equipment: General Requirements for Safety and ● Essential Performance.
IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General Requirements for ● Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
IEC 60601-1-3: 2008 Medical Electrical Equipment - Part 1-3: General Requirements for Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment
IEC 60601-2-54: 2009 Medical Electrical Equipment - Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy.

The DR 800 with Tomosynthesis is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 - 1020.32.

Agfa's in-house standard operating procedures were also used for the development of the device and software; these procedures conform to the following standards:

ISO 13485:2003 Medical Devices Quality Management Systems ●
ISO 14971:2012 Application of Risk Management to Medical Devices
IEC 62304:2006 Medical Device Software - Software life cycle processes
IEC 62366:2007 Medical Devices Application of Usability Engineering ●
ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM) ●

Guidance Documents

Agfa utilized the following guidance documents in the development of the DR 800 with Tomosynthesis:

Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (May 2005)
Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software . (January 2005)
Off-the-Shelf Software Use in Medical Devices (September 1999) ●
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2014)
Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (November 2017)

Summarv

Based on the performance data as documented in the above testing. the DR 800 is found to have a safety and effectiveness profile that is similar to the predicate devices.

{13}------------------------------------------------

VIII. CONCLUSIONS

Agfa's DR 800 has indications for use that is consistent with those of the legally marketed predicate devices (K132261 and K180589). Intended uses are the same. Where technological characteristics differ lab tests concluded that the device is substantially equivalent to the predicates in that it does not alter the intended therapeutic/diagnostic effect.

The new device and the Discovery XR656 with VolumeRAD primary predicate device (K132261) are tomographic x-ray systems Product Code IZF. The DR 800 with Tomosynthesis also has product code JAA which is identical the Agfa DR 800 with MUSICA Dymanic predicate device (K180589). Agfa's DR 800 with Tomosynthesis is substantially equivalent to both predicate devices (K132261 & K180589) in that it uses precisely the same technology to capture and transmit images.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

{14}------------------------------------------------

Regulation Number and Section

§ 892.1740 Tomographic x-ray system.

(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.